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Bariatric surgery and infertility treatment: unveiling insights for modern pharmacotherapy 减肥手术和不孕症治疗:揭示现代药物治疗的见解
IF 2.2
FS Reports Pub Date : 2025-09-01 DOI: 10.1016/j.xfre.2025.04.002
Emma Manuel M.D., M.P.H., Samantha B. Schon M.D., M.S.T.R
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引用次数: 0
Do children born after embryo vitrification differ from siblings born after fresh embryo transfer? 胚胎玻璃化后出生的孩子与新鲜胚胎移植后出生的孩子不同吗?
IF 2.2
FS Reports Pub Date : 2025-09-01 DOI: 10.1016/j.xfre.2025.07.007
Florence Belva M.D., Ph.D. , Christophe Blockeel M.D., Ph.D. , Mathieu Roelants Ph.D. , Kathelijn Keymolen M.D., Ph.D. , Neelke De Munck Ph.D. , Andrea Buysse B.S.N., B.S. Midwifery , Martine De Rycke Ph.D. Ir , Frederik J. Hes M.D., Ph.D. , Lisbet Van Landuyt Ph.D.
{"title":"Do children born after embryo vitrification differ from siblings born after fresh embryo transfer?","authors":"Florence Belva M.D., Ph.D. ,&nbsp;Christophe Blockeel M.D., Ph.D. ,&nbsp;Mathieu Roelants Ph.D. ,&nbsp;Kathelijn Keymolen M.D., Ph.D. ,&nbsp;Neelke De Munck Ph.D. ,&nbsp;Andrea Buysse B.S.N., B.S. Midwifery ,&nbsp;Martine De Rycke Ph.D. Ir ,&nbsp;Frederik J. Hes M.D., Ph.D. ,&nbsp;Lisbet Van Landuyt Ph.D.","doi":"10.1016/j.xfre.2025.07.007","DOIUrl":"10.1016/j.xfre.2025.07.007","url":null,"abstract":"<div><h3>Objective</h3><div>To assess neonatal outcomes in siblings born after frozen embryo transfer (FET) in comparison with siblings born after fresh embryo transfer.</div></div><div><h3>Design</h3><div>Prospective cohort study. Linear mixed models and generalized linear mixed models were used to study the association between outcomes after FET vs. fresh embryo transfer, considering the correlation of observations from siblings and controlling for treatment and maternal characteristics. Subgroup analysis according to the day of fresh embryo transfer and according to the FET protocol was also performed.</div></div><div><h3>Subjects</h3><div>Sibling pairs of singletons born to mothers who had both fresh and vitrified embryos transferred between 2008 and 2021, irrespective of the order (fresh-frozen or frozen-fresh) from a single center were included. Sibling pairs born after in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) and after embryo biopsy were considered.</div></div><div><h3>Exposure</h3><div>Women who had singleton deliveries after both fresh (cleavage stage or blastocyst stage) and vitrified (cleavage stage or blastocyst stage) embryo transfers.</div></div><div><h3>Main outcome measures</h3><div>Measurements at birth, as well as neonatal outcomes including prematurity, small-for-gestational age, large-for-gestational age (LGA), perinatal death and congenital malformations.</div></div><div><h3>Results</h3><div>Data were available for 1,185 sibling pairs born after IVF/ICSI and for 155 sibling pairs born after embryo biopsy. Higher mean birthweight standard deviation scores were found in FET siblings compared with siblings born after fresh embryo transfer, even after adjustment for treatment and maternal characteristics. This finding was confirmed in the subgroup analysis according to the day of fresh embryo transfer and according to the FET protocol. Frozen embryo transfer was associated with a lower risk of prematurity and a higher risk of LGA after adjustment for treatment and maternal characteristics. The rates of perinatal deaths and congenital malformations were comparable between siblings born after FET and fresh embryo transfer. Like the outcomes for IVF/ICSI sibling pairs, higher LGA rates and higher mean birthweight standard deviation scores were found for FET siblings born after embryo biopsy when compared with siblings born after fresh embryo transfer.</div></div><div><h3>Conclusion</h3><div>Our results in siblings born after IVF/ICSI and after embryo biopsy, indicated that FET is associated with higher birthweight, even after controlling for confounders.</div></div>","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"6 3","pages":"Pages 319-327"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145099962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Toward predictive andrology: integrating basic semen analysis mitochondrial deoxyribonucleic acid and artificial intelligence to forecast reproductive outcomes 预测男科:整合基本精液分析、线粒体脱氧核糖核酸和人工智能来预测生殖结果
IF 2.2
FS Reports Pub Date : 2025-09-01 DOI: 10.1016/j.xfre.2025.08.005
Nicolás Garrido M.Sc., Ph.D.
{"title":"Toward predictive andrology: integrating basic semen analysis mitochondrial deoxyribonucleic acid and artificial intelligence to forecast reproductive outcomes","authors":"Nicolás Garrido M.Sc., Ph.D.","doi":"10.1016/j.xfre.2025.08.005","DOIUrl":"10.1016/j.xfre.2025.08.005","url":null,"abstract":"","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"6 3","pages":"Pages 243-244"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145100111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Removal notice 删除通知
IF 2.2
FS Reports Pub Date : 2025-09-01 DOI: 10.1016/j.xfre.2025.09.001
{"title":"Removal notice","authors":"","doi":"10.1016/j.xfre.2025.09.001","DOIUrl":"10.1016/j.xfre.2025.09.001","url":null,"abstract":"","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"6 3","pages":"Page 407"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145100232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effect of music on anxiety during intrauterine insemination: a randomized controlled trial 音乐对宫内授精期间焦虑的影响:一项随机对照试验
IF 2.2
FS Reports Pub Date : 2025-09-01 DOI: 10.1016/j.xfre.2025.05.008
Sarah C. Baumgarten M.D., Ph.D. , Valerie Chen M.D. , Alicia J. Ogle A.P.R.N. , Angela J. Fought M.S. , Yan Li Ph.D. , Alessandra J. Ainsworth M.D.
{"title":"Effect of music on anxiety during intrauterine insemination: a randomized controlled trial","authors":"Sarah C. Baumgarten M.D., Ph.D. ,&nbsp;Valerie Chen M.D. ,&nbsp;Alicia J. Ogle A.P.R.N. ,&nbsp;Angela J. Fought M.S. ,&nbsp;Yan Li Ph.D. ,&nbsp;Alessandra J. Ainsworth M.D.","doi":"10.1016/j.xfre.2025.05.008","DOIUrl":"10.1016/j.xfre.2025.05.008","url":null,"abstract":"<div><h3>Objective</h3><div>To study the effect of music therapy on patient-reported anxiety and pain during intrauterine insemination (IUI) procedures.</div></div><div><h3>Design</h3><div>Randomized, controlled trial (NCT05492331).</div></div><div><h3>Subjects</h3><div>Patients aged 18 to 45 years undergoing IUI.</div></div><div><h3>Intervention</h3><div>Participants were randomly assigned 1:1 to either the music intervention group or nonmusic group. Those randomized to the music therapy group selected their music preference.</div></div><div><h3>Main Outcome Measures</h3><div>Differences in mean anxiety and pain between music and nonmusic groups before, during, and after IUI procedure, as assessed by visual analogue scale and Wong Baker pain scale, respectively.</div></div><div><h3>Results</h3><div>100 patients met inclusion criteria and were randomly assigned to listen to music (n = 50) or no music (n = 50) during their IUI. Baseline factors were similar between groups. There was no difference in patient-reported anxiety or pain scores before or during the IUI procedure. Participants in the music intervention group reported lower post-procedure anxiety scores (12.0, 95% confidence interval [8.3, 15.8] vs. 18.6, 95% confidence interval [13.6, 23.5]) compared with controls and expressed a high degree of satisfaction (92%) with this intervention. Participants in both groups expressed a desire for music therapy in future IUI procedures (88% vs. 68% in the music therapy vs no music groups, respectively).</div></div><div><h3>Conclusion</h3><div>Patients who listened to music during IUI reported lower anxiety scores at the conclusion of the procedure and had high satisfaction rates.</div></div><div><h3>Trial registration</h3><div>NCT05492331 (<span><span>https://clinicaltrials.gov/study/NCT05492331</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"6 3","pages":"Pages 381-387"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145100299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The impact of expectant management compared with intrauterine insemination with ovarian stimulation on quality of life and coital frequency in couples with unexplained subfertility 不明原因不孕不育夫妇的生活质量和性交频率与宫内人工授精加卵巢刺激的比较
IF 2.2
FS Reports Pub Date : 2025-09-01 DOI: 10.1016/j.xfre.2025.06.001
Jennifer A. Wessel M.D., Ph.D. , Monique H. Mochtar M.D., Ph.D. , Rik van Eekelen Ph.D. , Leoni A. Louwé M.D., Ph.D. , Eugenie M. Kaaijk M.D., Ph.D. , Mariëtte Goddijn M.D., Ph.D. , Madelon van Wely Ph.D. , Femke Mol M.D., Ph.D.
{"title":"The impact of expectant management compared with intrauterine insemination with ovarian stimulation on quality of life and coital frequency in couples with unexplained subfertility","authors":"Jennifer A. Wessel M.D., Ph.D. ,&nbsp;Monique H. Mochtar M.D., Ph.D. ,&nbsp;Rik van Eekelen Ph.D. ,&nbsp;Leoni A. Louwé M.D., Ph.D. ,&nbsp;Eugenie M. Kaaijk M.D., Ph.D. ,&nbsp;Mariëtte Goddijn M.D., Ph.D. ,&nbsp;Madelon van Wely Ph.D. ,&nbsp;Femke Mol M.D., Ph.D.","doi":"10.1016/j.xfre.2025.06.001","DOIUrl":"10.1016/j.xfre.2025.06.001","url":null,"abstract":"<div><h3>Objective</h3><div>To study the impact of 6 months of expectant management (EM) compared with 6 months of intrauterine insemination with ovarian stimulation (IUI-OS) on the health-related quality of life (HRQoL), anxiety and depression scores and the coital frequency in couples with unexplained subfertility and a poor prognosis for natural conception.</div></div><div><h3>Design</h3><div>A study alongside the ExIUI trial, a multicentre randomized controlled trial.</div></div><div><h3>Subjects</h3><div>Couples with unexplained subfertility and a poor prognosis for natural conception based on the score of Hunault.</div></div><div><h3>Intervention</h3><div>Women in both groups were asked to fill in the Fertility Quality of Life (FertiQol) and Hospital Anxiety and Depression Scale (HADS) questionnaires at 3 moments and to keep a diary with their periods and dates of coitus.</div></div><div><h3>Main Outcome Measures</h3><div>Health-related quality of life scores, anxiety and depression scores, and coital frequency.</div></div><div><h3>Results</h3><div>Of the 178 women, 161 (90%) filled in at least one questionnaire. Women allocated to EM scored significantly lower on the relational domain compared with women allocated to IUI-OS (overall mean difference, –5.93; 95% confidence interval [CI], –10.64 to –1.22). We found no difference between the two groups in the social domain (overall mean difference, –4.72; 95% CI, –9.88 to 0.45). No difference between the two was found in anxiety (overall mean difference, –0.20; 95% CI, –1.44 to 1.04) or depression scores (overall mean difference, 0.22; 95%CI, –0.86 to 1.30). Among all women allocated to either EM or IUI-OS, anxiety and depression scores increased over time. Seventy-nine (44%) out of 178 women filled in at least one month of their diary and reported on a total of 497 cycles and registered 2,026 dates of coitus. The median coital frequency per cycle was 4 (interquartile range [IQR]: 1–7) in the EM group and 3 (IQR: 0–7) in the IUI-OS group. The median coital frequency in the fertile window per cycle was 2 (IQR: 0–3) in EM and 1 (IQR: 0–3) in IUI-OS, which was a statistically significant difference.</div></div><div><h3>Conclusion</h3><div>Compared with IUI-OS, 6 months of EM resulted in a lower HRQoL on the relational domain, comparable anxiety and depression scores and higher coital frequency in the fertile window.</div></div><div><h3>Clinical Trial Registration Number</h3><div>Dutch Trial register NL5455 (NTR5599).</div></div>","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"6 3","pages":"Pages 374-380"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145100298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Extending letrozole dosing in patients with polycystic ovary syndrome undergoing ovulation induction with intrauterine insemination 在宫内人工授精诱导排卵的多囊卵巢综合征患者中扩大来曲唑的剂量
IF 2.2
FS Reports Pub Date : 2025-09-01 DOI: 10.1016/j.xfre.2025.06.002
Kara B. Fields M.D. , Sharrón L. Manuel M.D., Ph.D. , Anthony C. Leonard Ph.D. , Roshni Venkatesh B.S. , Michael A. Thomas M.D. , Emily G. Hurley M.D.
{"title":"Extending letrozole dosing in patients with polycystic ovary syndrome undergoing ovulation induction with intrauterine insemination","authors":"Kara B. Fields M.D. ,&nbsp;Sharrón L. Manuel M.D., Ph.D. ,&nbsp;Anthony C. Leonard Ph.D. ,&nbsp;Roshni Venkatesh B.S. ,&nbsp;Michael A. Thomas M.D. ,&nbsp;Emily G. Hurley M.D.","doi":"10.1016/j.xfre.2025.06.002","DOIUrl":"10.1016/j.xfre.2025.06.002","url":null,"abstract":"<div><h3>Objective</h3><div>To determine the effect of prescribing a second course of letrozole within a single ovulation induction/intrauterine insemination (OI/IUI) cycle on pregnancy outcomes in patients with polycystic ovary syndrome (PCOS).</div></div><div><h3>Design</h3><div>Retrospective cohort study.</div></div><div><h3>Subjects</h3><div>Cases designated as OI/IUI in PCOS patients using letrozole alone for OI were identified. Patient (n = 183) and cycle (n = 405) demographics and outcomes were collected. Cycles in which an adequate response was achieved with a single course of letrozole (n = 333) were compared with cycles in which a second course was needed to achieve adequate follicular growth (n = 72). A second course was indicated in cases of suboptimal follicular growth after the initial course of letrozole. The relationships between single vs. a second course and pregnancy-related outcomes were examined adjusting for age and body mass index in logistic regressions.</div></div><div><h3>Exposure</h3><div>Extended dosing with a second course of letrozole within an OI/IUI cycle in PCOS patients.</div></div><div><h3>Main Outcome Measures</h3><div>Clinical pregnancy.</div></div><div><h3>Results</h3><div>The clinical pregnancy rate was not significantly different for the extended-dose cycles (15.3%,11/72) compared with single-dose cycles (13.5%, 45/333) (odds ratio [95% confidence limit] = 1.15 [0.56–2.36]). After adjusting for age and body mass index, there remained no significant difference between groups.</div></div><div><h3>Conclusion</h3><div>Extended dosing with a second course of letrozole in an OI/IUI cycle is associated with no significant difference in pregnancy and live birth outcomes. Thus, it is reasonable to give a second course of letrozole in a patient with PCOS, if indicated, which helps optimize the number of cycles needed to achieve pregnancy.</div></div>","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"6 3","pages":"Pages 388-393"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145100300","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Prevention of ovarian hyperstimulation syndrome: optimizing habitual stimulation strategies 预防卵巢过度刺激综合征:优化习惯性刺激策略
IF 2.2
FS Reports Pub Date : 2025-09-01 DOI: 10.1016/j.xfre.2025.08.001
Alexander M. Quaas M.D., Ph.D.
{"title":"Prevention of ovarian hyperstimulation syndrome: optimizing habitual stimulation strategies","authors":"Alexander M. Quaas M.D., Ph.D.","doi":"10.1016/j.xfre.2025.08.001","DOIUrl":"10.1016/j.xfre.2025.08.001","url":null,"abstract":"","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"6 3","pages":"Pages 239-240"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145100012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Decision making of male same-sex couples pursuing pregnancy via assisted reproductive technology: a qualitative study 男性同性伴侣通过辅助生殖技术寻求怀孕的决策:一项定性研究
IF 2.2
FS Reports Pub Date : 2025-09-01 DOI: 10.1016/j.xfre.2025.05.007
Sean Dailey M.S., C.G.C. , MaryAnn Campion Ed.D., M.S., C.G.C. , Kimberly Zayhowski M.S., C.G.C. , Brent Monseur M.D., Sc.M.
{"title":"Decision making of male same-sex couples pursuing pregnancy via assisted reproductive technology: a qualitative study","authors":"Sean Dailey M.S., C.G.C. ,&nbsp;MaryAnn Campion Ed.D., M.S., C.G.C. ,&nbsp;Kimberly Zayhowski M.S., C.G.C. ,&nbsp;Brent Monseur M.D., Sc.M.","doi":"10.1016/j.xfre.2025.05.007","DOIUrl":"10.1016/j.xfre.2025.05.007","url":null,"abstract":"<div><h3>Objective</h3><div>To explore the decision-making of male same-sex couples when selecting sperm, donor eggs, and embryo(s) to transfer when using assisted reproductive technology (ART).</div></div><div><h3>Design</h3><div>Qualitative.</div></div><div><h3>Subjects</h3><div>Twenty participants: 8 successfully achieved pregnancy via ART, and 12 were actively pursuing pregnancy. Most participants were gay, White, cisgender men.</div></div><div><h3>Exposure</h3><div>Not applicable.</div></div><div><h3>Main Outcome Measures</h3><div>Reflexive thematic analysis of interview transcripts.</div></div><div><h3>Results</h3><div>Four themes related to the decision-making processes of male same-sex couples using ART were conceptualized from the data and included desire for actual or perceived genetic relatedness, actual or perceived risk mitigation, desire for control, and financial cost. Many couples preferred using ART because both partners wanted to contribute sperm to fertilize donor eggs. Couples often preferred using the same egg donor if they wanted more than one child, and many couples wanted to achieve a blended family by using an egg donor who looked like one or both partners. Many couples made decisions, such as genetically testing embryos or transferring a single embryo into a gestational carrier, on the basis of increasing the chances of a healthy pregnancy. Some couples wanted more control during the process; thus, they made decisions regarding sex selection because they had the option to. The high financial cost of ART was the largest barrier for many couples, causing many to make sacrifices to mitigate cost.</div></div><div><h3>Conclusion</h3><div>Decision-making of male same-sex couples pursuing ART is complex and unique to each couple. There are many stages throughout the process that require complicated decision-making; however, decisions are often shaped by the desire for genetic relatedness, risk reduction, control, and financial costs. Male same-sex couples often must make decisions without evidence-based medicine; thus, better clinical guidance is needed to allow reproductive experts to facilitate these delicate conversations and improve the experience of intended parents. The high cost makes the process more difficult for many couples, requiring many to make sacrifices and leaving many unable to pursue ART to build their families. Better insurance coverage needs to be made available to improve care for this marginalized patient population.</div></div>","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"6 3","pages":"Pages 350-356"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145099966","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety and pharmacology of AMY109, a long-acting anti–interleukin-8 antibody, for endometriosis: a double-blind, randomized phase 1 trial 长效抗白细胞介素-8抗体AMY109治疗子宫内膜异位症的安全性和药理学:一项双盲随机一期试验
IF 2.2
FS Reports Pub Date : 2025-09-01 DOI: 10.1016/j.xfre.2025.04.009
Peng-Hui Wang M.D., Ph.D. , Sheng-Mou Hsiao M.D. , Shunji Matsuki M.D., Ph.D. , Ryuzo Hanada M.D., Ph.D. , Chun-An Chen M.Sc. , Ayako Nishimoto-Kakiuchi Ph.D. , Mayuko Sekiya D.V.M. , Kiyohiko Nakai M.Sc. , Junnosuke Matsushima M.S.E. , Mari Sawada M.D.
{"title":"Safety and pharmacology of AMY109, a long-acting anti–interleukin-8 antibody, for endometriosis: a double-blind, randomized phase 1 trial","authors":"Peng-Hui Wang M.D., Ph.D. ,&nbsp;Sheng-Mou Hsiao M.D. ,&nbsp;Shunji Matsuki M.D., Ph.D. ,&nbsp;Ryuzo Hanada M.D., Ph.D. ,&nbsp;Chun-An Chen M.Sc. ,&nbsp;Ayako Nishimoto-Kakiuchi Ph.D. ,&nbsp;Mayuko Sekiya D.V.M. ,&nbsp;Kiyohiko Nakai M.Sc. ,&nbsp;Junnosuke Matsushima M.S.E. ,&nbsp;Mari Sawada M.D.","doi":"10.1016/j.xfre.2025.04.009","DOIUrl":"10.1016/j.xfre.2025.04.009","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate the safety and pharmacokinetics/pharmacodynamics of AMY109, an anti–interleukin-8 recycling antibody in a first-in-human phase 1 trial in healthy volunteers (HVs) and patients with endometriosis.</div></div><div><h3>Design</h3><div>A multicenter, randomized, double-blind, placebo-controlled single-dose and multiple ascending-dose study in Japan and Taiwan.</div></div><div><h3>Subjects</h3><div>Asian and White HVs in part 1 and patients with endometriosis aged ≥20 to &lt;50 years in part 2.</div></div><div><h3>Intervention</h3><div>In part 1, sequential cohorts of HVs randomly received a single subcutaneous dose of AMY109 (0.6, 2.0, 3.5, or 5.0 mg/kg) or placebo. In part 2, sequential cohorts of patients with endometriosis randomly received a once-monthly subcutaneous dose of AMY109 (0.8, 2.0, or 5.0 mg/kg) or placebo for 6 months.</div></div><div><h3>Main Outcome Measures</h3><div>The primary objective was to assess the safety and tolerability of AMY109. Pharmacokinetic profiles and efficacy were evaluated as secondary and exploratory endpoints, respectively.</div></div><div><h3>Results</h3><div>Overall, 42.1% (32/76) of HVs in part 1 and 61.5% (16/26) of patients in part 2 experienced at least one adverse event during the study. The most common adverse events were oropharyngeal pain, pharyngitis, upper respiratory tract infections, and upper respiratory tract inflammation in part 1 (≥5.0%) and vomiting, nasopharyngitis, diarrhea, nausea, and vaccination site pain in part 2 (≥15.0%). Most events were mild to moderate in severity and were resolved/resolving at last follow-up. Of note, menstrual bleeding in patients with endometriosis was not interrupted during AMY109 treatment. Pharmacokinetic analysis showed that AMY109 had a long half-life (40 days) and exhibited linear pharmacokinetics across all cohorts.</div></div><div><h3>Conclusion</h3><div>AMY109 demonstrated acceptable safety and pharmacokinetic profiles in HVs (single dose of 0.6–5.0 mg/kg) and patients with endometriosis (multiple doses of 0.8–5.0 mg/kg/month for 6 months). These results support further clinical development of AMY109 for endometriosis and other diseases influenced by interleukin-8.</div></div><div><h3>Trial registration number</h3><div>AMY001JG study; JapicCTI-183841. Trial registration date: January 25, 2018. Date of first participant’s enrolment: February 26, 2018.</div></div>","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"6 3","pages":"Pages 261-269"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145100014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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